Biography
Biography: Kamali Chance
Abstract
The regulatory landscape for the development of biosimilars in the US and EU is dynamic as many of the guidances issued by European Medicines Agency (EMA) have undergone revisions and in 2015, the FDA issued number of revised guidelines for Quality and Scientific Considerations as well as updated Questions and Answers documents that lend much clarity as to FDA expectations.The thinking of the regulators both in the EU and US has evolved over the years and there is a great deal of convergence. This session is designed to provide current status of biosimilar guidelines in the US and EU. The focus will be to identify major updates in order to help sponsors navigate through the complex requirements for the regulatory approval of biosimilars in the US and EU.
